Olympus Medical Systems Corporation
Dispositifs autorisés FDA 510(k) et PMA — 36 produits
Publicité
Nombre total de dispositifs36
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | FDS | 2026-08-27 | Voir |
| 510(k) | K260856 | Disposable Distal Attachment D-201-13404 | FDS | 2026-08-27 | Voir |
| 510(k) | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | PSV | 2026-08-27 | Voir |
| 510(k) | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | 2026-07-31 | Voir |
| 510(k) | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | FET | 2026-06-24 | Voir |
| 510(k) | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | EOB | 2026-03-20 | Voir |
| 510(k) | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | FDX | 2025-12-18 | Voir |
| 510(k) | K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | KNS | 2025-11-25 | Voir |
| 510(k) | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | FGE | 2025-10-21 | Voir |
| 510(k) | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | FBK | 2025-10-16 | Voir |
| 510(k) | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | KNS | 2025-10-10 | Voir |
| 510(k) | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | GEI | 2025-10-07 | Voir |
| 510(k) | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | KGE | 2025-10-07 | Voir |
| 510(k) | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | 2025-10-03 | Voir |
| 510(k) | K251986 | Tuyau d'eau d'appoint MAJ-855 | OCX | 2025-09-26 | Voir |
| 510(k) | K251997 | Single-Use Biopsy Valve (MAJ-1555) | OCX | 2025-09-25 | Voir |
| 510(k) | K250883 | PROBE ULTRASONIQUE UM-3R (UM-3R); PROBE ULTRASONIQUE UM-G20-29R (UM-G20-29R) | ITX | 2025-09-18 | Voir |
| 510(k) | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | KTI | 2025-07-29 | Voir |
| 510(k) | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | ODC | 2025-07-16 | Voir |
| 510(k) | K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | ITX | 2025-07-11 | Voir |
Aucun dispositif correspondant.